Remarkable information about HIV tests including the fact that no HIV test
has ever been approved by the US Food and Drug Administration for the
actual diagnosing of HIV infection.

Few doctors, clinics, journalists, or AIDS organizations know that all
current HIV tests are approved only as screening tests, prognostic tests
(for predicting a possible future outcome) or as "an aid in diagnosis" and
are not intended to be used for determining if a person actually has HIV.

The FDA's lack of such approval speaks to the fact that no HIV test can
directly detect or quantify HIV or determine the presence of specific HIV
antibodies in human blood.

Recent changes in the fine print of the test kits acknowledge this little
known data and seem to indicate a change of thought with regard to the
role of HIV in AIDS.

From 1984 until last year, test literature contained the very certain
statement that "AIDS is CAUSED by HIV." Then in November of 2002, a new
test kit started what now seems to be a trend toward rethinking the causal
link between HIV and AIDS. It states, "AIDS, AIDS related complex and
pre-AIDS
are THOUGHT TO BE CAUSED by HIV." (OraQuick Rapid HIV-1 Antibody Test,
OraSure Technologies, Inc)

Now it appears we've gone from "HIV is thought to cause AIDS," to
something even more uncertain: "Published data indicate A STRONG
CORRELATION between the acquired immunodeficiency syndrome (AIDS) and a
retrovirus REFERRED TO as Human Immunodeficiency Virus (HIV)."

This last quote is found in the package insert for a new ELISA test
(Vironostika HIV-1 Plus O Microelisa System) the FDA approved in June
2003.
The entire package insert can be downloaded from

http://www.fda.gov/cber/pma/P020066.htm

According to Alive & Well advisor Dr Rodney Richards, a chemist and
co-creator of the very first HIV test, as of June 2003, the number of FDA
approved tests that contain the term HIV or LAV (the old school term for
the so-called virus) have risen to 36. Of these, 13 have been approved in
just the last three years.

Richards points out that "despite the increased number of HIV tests, there
is still no manufacturer that claims their test can be used to diagnose
infection with HIV. All of the RNA based tests for viral load and
genotyping clearly state they are 'NOT intended for use in diagnosing HIV
infection.'
Instead of an indication for use in detecting or quantifying the actual
virus, these tests are approved only for prognosis or monitoring therapy
for people who doctors assume are infected.�

Richards is working on a do***ent to clarify what HIV test
manufacturers mean by the terms "prognosis," "monitoring of therapy," and
"aid in the diagnosis of HIV." His report will focus on what the tests
cannot do (diagnose HIV infection) and what exactly they can.

At first glance, the rapid tests may appear relatively benign since the
manufacturers clearly emphasize that "preliminary positives" must be
confirmed with follow up testing. This emphasis is due to the fact that
the accuracy of the rapid tests� is widely known to be more
questionable than the already dubious HIV ELISA or Western Blot. But the
notion that
medical personnel will await confirmation of results before insisting
patients take action is entirely misguided since the true market for rapid
tests is pregnant women in labor

Incredibly, the recommendation to misuse rapid tests for women in labor
comes directly from the Deputy Commissioner of the FDA himself, Dr. Lester
M Crawford. The good doctor says "OraQuick will be a great help in
identifying pregnant HIV-infected women going into labor who were not
tested during pregnancy so that precautionary steps can be taken to block
their newborns from being infected with HIV." (FDA News, November 7,
2002)

These precautionary steps include IV infusion of the toxic chemotherapy
AZT during labor, C-section delivery, six weeks of mandatory AZT treatment
for the baby regardless of their own HIV status, and orders to the mother
not to breastfeed. Even though chemotherapy, surgery and denial of normal
feeding are based on preliminary results from a test never approved for
detecting HIV infection, a mother who declines such intervention risks
losing custody of her child.

Perhaps more remarkable than official calls for misuse of rapid tests is a
disclosure by the manufacturer of the OraQuick that 7% of women with a
history of prior pregnancy will score falsely positive on their test.
Further, the manufacturer of the newly approved Reveal test didn't even
evaluate their product in multiparous women.

Worse still, as Dr Richards points out, the rapid tests may soon be
routinely administered to women tested negative before labor. "Based on
the erroneous belief these tests can actually diagnose HIV infection,
doctors may want to retest women in labor who�ve previously come up
negative just to
be sure they haven't seroconverted in the mean time."

Another lucrative market for the rapid tests is among healthcare workers
who experience accidental needle sticks or other unintentional contact
with patient fluids. As Richard points out, this opens a Pandora�s
box of potential life-altering situations.

"Imagine a nurse sticks herself with a used needle. Ora-Sure gives her the
impression she can find out quickly if that needle is contaminated with
HIV. Should the needle score positive, she would then be urged to start
prophylactic chemotherapy right away. Of course, if the needle scores
positive, hospitals would most likely feel an ethical responsibility to
inform the patient and to urge them to also start 'saving their lives'
with AIDS meds. Since there are 600,000 to 1,000,000 accidental needles
sticks in the US annually, this is a huge market for both the test and
treatment manufacturers."

The great influence of drug and test manufacturers on public health
policy, media presentations and among AIDS activist groups may mean that
the hidden dangers of rapid tests will remain unknown.